LLD #1 Lead Locking Device 518-021Recalls & reported problems
Spectranetics Corporation · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00813132023003), received between Aug 4, 2023 and Aug 4, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A LEAD EXTRACTION PROCEDURE COMMENCED TO REMOVE A RIGHT ATRIAL (RA) AND TWO RIGHT VENTRICULAR (RV) LEADS (ONE ACTIVE, ONE ABANDONED) DUE TO CIED SYSTEM/POCKET INFECTION. INSERTION OF SPECTRANETICS LEAD LOCKING DEVICES (LLDS) WERE ATTEMPTED IN THE ABANDONED AND THE ACTIVE RV LEADS TO PROVIDE TRACTION, BUT COULD NOT BE ADVANCED FARTHER THAN THE MIDDLE OF THE LEADS, AND WERE REMOVED. AN LLD WAS SUCCESSFULLY PLACED IN THE RA LEAD, AND A SPECTRANETICS 9F TIGHTRAIL SUB-C ROTATING DILATOR SHEATH WAS USED TO REMOVE ADHESIONS IN THE SUBCLAVIAN REGION. A SPECTRANETICS 12F GLIDELIGHT LASER SHEATH WAS USED NEXT; HOWEVER, PROGRESS STALLED NEAR THE SUPERIOR VENA CAVA (SVC) REGION DUE TO CALCIUM. AN LLD WAS THEN INSERTED IN THE ACTIVE RV LEAD, WHICH COULD ONLY BE ADVANCED TO THE MIDDLE OF THE LEAD, AND WAS LOCKED IN PLACE. USING THE SAME TIGHTRAIL SUB-C AND GLIDELIGHT DEVICES, PROGRESS STALLED IN THE SVC REGION, SAME AREA WHERE PROGRESS STALLED ON THE RA LEAD. DUE TO HEAVY FIBROSIS/CALCIFICATIONS, THE PATIENT'S ADVANCED AGE, AND THAT THE EXTRACTION ATTEMPTS CONTINUED FOR NEARLY 4 HOURS, IT WAS DETERMINED THERE WAS NO WAY TO EXTRACT THESE LEADS. THE PHYSICIAN DID NOT ATTEMPT TO UNLOCK THE LLDS FRO
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17461330 ↗
Other Stylet, Catheter devices
- LLD EZ Lead Locking Device 518-062Spectranetics Corporation · Stylet, Catheter18 deaths322 reports
- LLD #2 Lead Locking Device 518-019Spectranetics Corporation · Stylet, Catheter2 deaths62 reports
- LLD EZ Lead Locking Device 518-067Spectranetics Corporation · Stylet, Catheter1 death23 reports
- Liberator Beacon Tip G26550Cook Vandergrift Inc. · STYLET, CATHETER2 deaths20 reports
- LLD E Lead Locking Device 518-039Spectranetics Corporation · Stylet, Catheter18 reports
- LLD #2 Lead Locking Device 518-022Spectranetics Corporation · Stylet, Catheter10 reports
- LLD #1 Lead Locking Device 518-018Spectranetics Corporation · Stylet, Catheter7 reports
- NA 6057-58Medtronic, Inc. · STYLET, CATHETER2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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